New approach to fighting heart disease
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HARVARD: Doctors try reducing inflammation to cut heart-attack risk. The best protection against heart attack and stroke is to target certain risk factors with drugs and lifestyle changes. By quitting smoking, controlling high blood pressure, lowering high blood cholesterol and high blood sugar levels, and losing extra pounds, many people can substantially reduce the risk of developing atherosclerosis, a disease that can block arteries and lead to a heart attack or stroke. But these interventions aren't always enough to prevent heart attacks and strokes.
That's why researchers are targeting inflammation, an injury fighting process that contributes to atherosclerosis. This year, two clinical trials will test whether reducing inflammation adds any additional protection against heart attack and stroke. "We believe that this concept has enormous potential as a new method to reduce the burden of heart attack and stroke," says Dr. Paul Ridker, director of the Center for Cardiovascular Disease Prevention at Harvard-affiliated Brigham and Women's Hospital.
Dr. Ridker will serve as principal investigator of both clinical trials. Cigarette smoke, high blood pressure, high cholesterol, and other traditional risk factors for cardiovascular disease are known to irritate and damage the cells that line our arteries. The body is often able to repair this damage. But when the irritation continues for many years, the arteries remain inflamed, and a long-term inflammatory process sets in. Harmful LDL cholesterol is attracted to the injury, where it accumulates and grows into deposits called plaques. Plaques can become large enough to restrict blood flow through a coronary artery. They can also rupture, causing a heart attack or stroke. The first clinical trial evidence that treating inflammation might lower this risk came in the late 1980s, when the Harvard-based Physicians Health Study demonstrated that daily aspirin could prevent first heart attacks in men. In addition to preventing platelets from clumping and forming clots, aspirin reduces inflammation.
In the late 1990s, Dr. Ridker and colleagues analyzed data from that clinical trial and found that men with higher levels of inflammation had three times the risk of heart attack and twice the risk of stroke than men with little or no chronic inflammation. Those with the most inflammation benefited the most from aspirin-leading the researchers to wonder whether using more powerful anti-inflammatory drugs would achieve even better results. Today, inflammation is measured with a high-sensitivity Creactive protein (hsCRP) test. A level higher than 3 milligrams per deciliter (mg/dL) denotes an increased risk for future heart attack and stroke. It is thought that long-lasting inflammation in the coronary arteries contributes to the development of heart disease. Harvard researchers are heading two clinical trials designed to determine whether reducing inflammation with powerful drugs can help protect against heart disease.
All eyes on these trials
The trials Dr Ridker will spearhead are designed to help determine whether reducing or eliminating inflammation can protect people with heart disease against heart attack and stroke. The Cardiovascular Inflammation Reduction Trial, funded by the National Institutes of Health, will investigate the impact of the anti-inflammatory drug methotrexate (Trexall, Rheumatrex) on 7,000 adults with diabetes or prediabetes who have already suffered a heart attack. The best available treatments often fail in these individuals, who are at very high risk for a second heart attack or stroke.
Methotrexate was chosen, in part, because people with rheumatoid arthritis (RA) who take methotrexate tend to have fewer heart attacks and strokes than their peers. The dose of methotrexate to be used in the trial is similar to the low dose commonly used to control RA. Methotrexate has also been shown to slow the progression of atherosclerosis, at least in animal models. The second clinical trial, funded by the pharmaceutical company Novartis, will test the company's antiinflammatory drug canakinumab (Ilaris) in 17,000 people with stable coronary artery disease and high levels of inflammation. Canakinumab is an antibody that is given as an injection every three months.
If the trial is successful, canakinumab may be used as a "vaccination" against heart disease. Both drugs target inflammation, and have little or no effect on other cardiovascular risk factors. With heart attack being the No. 1 killer in the United States, and stroke holding steady in fourth place, doctors are excited about the possibility of using this new approach to lower the risk of these often-deadly events. "Whether or not reducing inflammation can benefit our patients is a crucial question to answer. If these trials produce good results, they have the potential to dramatically reshape how we think about and treat heart disease," says Dr. Ridker. —MCT
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